Trials / Completed
CompletedNCT02262182
Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® After Cardiac Surgery in the Management of Postoperative Atelectasis
Evaluation of the Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® Device Associated With Respiratory Physiotherapy in the Treatment of Postoperative Pulmonary Atelectasis in Patients After Cardiac Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Pulmonary atelectasis is a frequent respiratory postoperative complication in cardiac surgery. Classically, the treatment of these patients is based on manual chest physiotherapy. Our objective is to evaluate the interest of association of positive end expiratory delivery sessions with the EzPAP® device. We perform a prospective monocentric, open label trial. Patients with atelectasis after scheduled cardiac surgery with cardiopulmonary bypass are included. They benefit from manual chest therapy and are randomised to receive or not positive end expiratory pressure sessions twice a day. The primary endpoint is the effect of this treatment on atelectasis radiological score after 2 days of treatment. The secondary endpoints are: oxygen saturation(SpO2)/inspired oxygen(FiO2) ratio, qualitative evaluation of ventilatory function, respiratory \& cardiac rate, pain, inspiratory pressure (sniff test), patient satisfaction, duration of intensive care unit (ICU) and hospital stay.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | KP group | |
| OTHER | KM group |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2014-10-10
- Last updated
- 2016-09-29
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02262182. Inclusion in this directory is not an endorsement.